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https://www.readbyqxmd.com/read/29341192/population-pharmacokinetic-modeling-of-guselkumab-a-human-igg1%C3%AE-monoclonal-antibody-targeting-il-23-in-patients-with-moderate-to-severe-plaque-psoriasis
#1
Zhenling Yao, Chuanpu Hu, Yaowei Zhu, Zhenhua Xu, Bruce Randazzo, Yasmine Wasfi, Yang Chen, Amarnath Sharma, Honghui Zhou
Psoriasis is a common inflammatory skin disorder that requires chronic treatment and is associated with multiple comorbidities. Guselkumab, a human immunoglobulin-G1-lambda monoclonal antibody, binds to interleukin-23 with high specificity and affinity and is effective in treating moderate to severe plaque psoriasis. As part of the guselkumab psoriasis clinical trial program, using a confirmatory approach, a population pharmacokinetics (PopPK) model was established using 13 014 PK samples from 1454 guselkumab-treated patients across 3 phase 2/3 trials...
January 17, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29341179/better-characterization-of-vinflunine-pharmacokinetics-variability-and-exposure-toxicity-relationship-to-improve-its-use-analyses-from-18-trials
#2
A Schmitt, L Nguyen, G Zorza, P Ferré, A Pétain
AIMS: Vinflunine is a novel tubulin-targeted inhibitor indicated as a single agent for the treatment of bladder cancers after failure of prior platinum-based therapy. Its pharmacokinetics (PK) and pharmacodynamics (PD) have been independently characterized through several phase I and phase II studies. However, no global pharmacometric analysis had been conducted yet. METHODS: Vinflunine concentrations and safety data from 18 phase I and phase II studies were used to conduct population PK and PK/PD analysis, using Nonmem...
January 17, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29333376/anti-inflammatory-and-anti-obesity-properties-of-food-bioactive-components-effects-on-adipose-tissue
#3
REVIEW
Shasika Jayarathne, Iurii Koboziev, Oak-Hee Park, Wilna Oldewage-Theron, Chwan-Li Shen, Naima Moustaid-Moussa
Obesity is an epidemic and costly disease affecting 13% of the adult population worldwide. Obesity is associated with adipose tissue hypertrophy and hyperplasia, as well as pathologic endocrine alterations of adipose tissue including local and chronic systemic low-grade inflammation. Moreover, this inflammation is a risk factor for both metabolic syndrome (MetS) and insulin resistance. Basic and clinical studies demonstrate that foods containing bioactive compounds are capable of preventing both obesity and adipose tissue inflammation, improving obesity-associated MetS in human subjects and animal models of obesity...
December 2017: Preventive Nutrition and Food Science
https://www.readbyqxmd.com/read/29330204/pazopanib-exposure-relationship-with-clinical-efficacy-and-safety-in-the-adjuvant-treatment-of-advanced-renal-cell-carcinoma
#4
Cora Sternberg, Frede Donskov, Naomi B Haas, Christian Doehn, Paul Russo, Mohamed A Elmeliegy, Guillaume Baneyx, Hiya Banerjee, Paola Aimone, Robert J Motzer
PURPOSE: PROTECT, a phase III randomized placebo-controlled study, evaluated pazopanib efficacy and safety in the adjuvant RCC setting. The relationship between pazopanib exposure (Ctrough) and efficacy and safety was evaluated. EXPERIMENTAL DESIGN: Evaluable steady-state blood trough concentrations were collected from 311 patients at week 3 or 5 (early Ctrough), and 250 patients at week 16 or 20 (late Ctrough). Pazopanib pharmacokinetic (PK) data was analyzed via a population model approach...
January 12, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29321332/erk-is-a-critical-regulator-of-jc-polyomavirus-infection
#5
Jeanne K DuShane, Michael P Wilczek, Colleen L Mayberry, Melissa S Maginnis
The human JC polyomavirus (JCPyV) infects the majority of the population worldwide and presents as an asymptomatic, persistent infection in the kidney. In individuals who are immunocompromised, JCPyV can become reactivated and cause a lytic infection in the central nervous system resulting in the fatal, demyelinating disease progressive multifocal leukoencephalopathy (PML). Infection is initiated by interactions between the capsid protein viral protein 1 (VP1) and the α2,6-linked sialic acid on LSTc, while JCPyV internalization is facilitated by 5-hydroxytryptamine 2 receptors (5-HT2Rs)...
January 10, 2018: Journal of Virology
https://www.readbyqxmd.com/read/29319935/clinical-bioavailability-of-the-novel-bace1-inhibitor-lanabecestat-azd3293-assessment-of-tablet-formulations-versus-an-oral-solution-and-the-impact-of-gastric-ph-on-pharmacokinetics
#6
Naidong Ye, Scott A Monk, Pankaj Daga, David M Bender, Laura B Rosen, Jamie Mullen, Margaret C Minkwitz, Alan R Kugler
The relative bioavailability of lanabecestat administered as 2 tablet formulations versus an oral solution was investigated. This phase 1 single-center, open-label, randomized, 3-period crossover study involved healthy male and nonfertile female subjects aged 18-55 years (NCT02039180). Subjects received a single 50-mg lanabecestat dose as solution, tablet A, or tablet B on day 1 of each crossover period; 14 of 16 subjects completed the study. Relative bioavailability based on plasma lanabecestat AUC0-∞ (area under the plasma drug concentration-time curve from zero to infinity) geometric mean ratio versus oral solution (primary variable) was: tablet A, 1...
January 10, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29316830/use-of-monte-carlo-simulation-to-evaluate-the-efficacy-of-tigecycline-and-minocycline-for-the-treatment-of-pneumonia-due-to-carbapenemase-producing-klebsiella-pneumoniae
#7
Wentao Ni, Guobao Li, Jin Zhao, Junchang Cui, Rui Wang, Zhancheng Gao, Youning Liu
BACKGROUND: Pneumonia caused by carbapenemase-producing Klebsiella pneumoniae (CP-KP) are increasingly encountered in hospitals worldwide, causing high mortality due to lack of treatment options. The goal of this study was to assess the efficacy of tigecycline and minocycline for CP-KP hospital-acquired pneumonia (HAP) by using Monte Carlo simulation. METHODS: A total of 164 non-duplicated CP-KP strains were collected from sputum or blood in patients with HAP. The MICs for antimicrobials were determined by the agar dilution method...
January 9, 2018: Infectious Diseases
https://www.readbyqxmd.com/read/29311482/population-pharmacokinetics-and-adverse-events-of-erlotinib-in-japanese-patients-with-non-small-cell-lung-cancer-impact-of-genetic-polymorphisms-in-metabolizing-enzymes-and-transporters
#8
Chihiro Endo-Tsukude, Ji-Ichiro Sasaki, Sho Saeki, Norihiro Iwamoto, Megumi Inaba, Sunao Ushijima, Hiroto Kishi, Shinji Fujii, Hiroshi Semba, Kosuke Kashiwabara, Yukari Tsubata, Mitsuhiro Hayashi, Yuki Kai, Hideyuki Saito, Takeshi Isobe, Hirotsugu Kohrogi, Akinobu Hamada
Determinants of interindividual variability in erlotinib pharmacokinetics (PK) and adverse events remain to be elucidated. This study with 50 Japanese non-small-cell lung cancer patients treated with oral erlotinib at a standard dose of 150 mg aimed to investigate whether genetic polymorphisms affect erlotinib PK and adverse events. Single nucleotide polymorphisms (SNPs) in genes encoding metabolizing enzymes (CYP1A1, CYP1A2, CYP2D6, CYP3A4, CYP3A5, UGT1A1, UGT2B7, GSTM1, and GSTT1) or efflux transporters (ABCB1, and ABCG2) were analyzed as covariates in a population PK model...
2018: Biological & Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/29311094/pharmacokinetics-of-telavancin-at-fixed-doses-in-normal-body-weight-and-obese-classes-i-ii-and-iii-adult-subjects
#9
Kristen L Bunnell, Manjunath P Pai, Monica Sikka, Susan C Bleasdale, Eric Wenzler, Larry H Danziger, Keith A Rodvold
A recommended total body weight (TBW) dosing strategy for telavancin may not be optimal in obese patients. The primary objective of this study was to characterize and compare the pharmacokinetics (PK) of telavancin across four body size groups: normal to overweight and obesity classes I, II, and III. Healthy adult subjects (n=32) received a single, weight-stratified, fixed dose of 500 mg (n=4), 750 mg (n=8) or 1000 mg (n=20) of telavancin. Noncompartmental PK analyses revealed subjects with body mass index (BMI) ≥ 40 kg/m2 had a higher volume of distribution (16...
January 8, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29311071/population-pharmacokinetics-of-polymyxin-b-in-acutely-ill-adult-patients
#10
Cristina Miglis, Nathaniel J Rhodes, Sean Avedissian, Christine J Kubin, Michael T Yin, Brian Nelson, Manjunath P Pai, Marc H Scheetz
Polymyxin B (PB) has reemerged as a common treatment against multidrug-resistant Gram-negative pathogens. However, nephrotoxicity remains a significant dose-limiting side effect and contemporary pharmacokinetic (PK) data is limited. This study sought to evaluate PB exposure differences in various load and non-loading strategies according to total body weight (TBW) and adjusted body weight (ABW). Patients treated with PB had plasma samples obtained for clinical care and analyzed using LC-MS/MS. Compartmental PK models with linear and allometric scaling of TBW were explored...
January 8, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29311066/population-pharmacokinetics-of-intravenous-polymyxin-b-from-clinical-samples
#11
Christine J Kubin, Brian C Nelson, Cristina Miglis, Marc H Scheetz, Nathaniel Rhodes, Sean Avedissian, Serge Cremers, Michael T Yin
A retrospective study was conducted in hospitalized patients receiving intravenous polymyxin B who underwent therapeutic drug monitoring during treatment. The aim of this study was to assess the population pharmacokinetics (PK) of intravenous polymyxin B in patients with variable total body weights and create a population model for clinical use. Nonlinear mixed-effects modeling analyses were performed. A total of 43 patients were included: 70% were male with a median age of 58 years and a median weight of 78 kg...
January 8, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29310479/therapies-for-multidrug-resistant-and-extensively-drug-resistant-non-fermenting-gram-negative-bacteria-causing-nosocomial-infections-a-perilous-journey-toward-molecularly-targeted-therapy
#12
Nadim G El Chakhtoura, Elie Saade, Alina Iovleva, Mohamad Yasmin, Brigid Wilson, Federico Perez, Robert A Bonomo
Non-fermenting Gram-negative bacilli are at the center of the antimicrobial resistance epidemic. Acinetobacter baumannii and Pseudomonas aeruginosa are both designated with a threat level to human health of "serious" by the Centers for Disease Control and Prevention. Two other major non-fermenting Gram-negative bacilli, Stenotrophomonas maltophilia and Burkholderia cepacia complex, while not as prevalent, have devastating effects on vulnerable populations, such as those with cystic fibrosis, as well as immunosuppressed or hospitalized patients...
January 9, 2018: Expert Review of Anti-infective Therapy
https://www.readbyqxmd.com/read/29305956/pharmacokinetics-of-colistin-methanesulfonate-cms-in-healthy-chinese-subjects-after-single-and-multiple-intravenous-doses
#13
Miao Zhao, Xiao-Jie Wu, Ya-Xin Fan, Ying-Yuan Zhang, Bei-Ning Guo, Ji-Cheng Yu, Guo-Ying Cao, Yuan-Cheng Chen, Ju-Fang Wu, Yao-Guo Shi, Jian Li, Jing Zhang
High prevalence of extensive-drug resistance (XDR) gram-negative pathogens has forced clinicians to use colistin as the last-line therapy. Our knowledge on the pharmacokinetics (PK) of colistin methanesulfonate (CMS, an inactive prodrug) and colistin has increased substantially; however, the PK in Chinese population is still unknown due to the lack of a CMS product. This study aimed to evaluate the PK of a new CMS product developed in China for optimizing the dosing regimens. Twenty-four healthy subjects (12 female, 12 male) were enrolled in single- and multiple-dose PK studies...
January 3, 2018: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/29305823/semi-mechanistic-population-pharmacokinetic-modeling-of-l-histidine-disposition-and-brain-uptake-in-wildtype-and-pht1-null-mice
#14
Xiao-Xing Wang, Yang-Bing Li, Meihua R Feng, David E Smith
PURPOSE: To develop a semi-mechanistic population pharmacokinetic (PK) model to quantitate the disposition kinetics of L-histidine, a peptide-histidine transporter 1 (PHT1) substrate, in the plasma, cerebrospinal fluid and brain parenchyma of wildtype (WT) and Pht1 knockout (KO) mice. METHODS: L-[14C]Hisidine (L-His) was administrated to WT and KO mice via tail vein injection, after which plasma, cerebrospinal fluid (CSF) and brain parenchyma samples were collected...
January 5, 2018: Pharmaceutical Research
https://www.readbyqxmd.com/read/29305560/heart-failure-with-preserved-ejection-fraction-controversies-challenges-and-future-directions
#15
REVIEW
Rosita Zakeri, Martin R Cowie
Heart failure with preserved ejection fraction (HFpEF) comprises almost half of the population burden of HF. Because HFpEF likely includes a range of cardiac and non-cardiac abnormalities, typically in elderly patients, obtaining an accurate diagnosis may be challenging, not least due to the existence of multiple HFpEF mimics and a newly identified subset of patients with HFpEF and normal plasma natriuretic peptide concentrations. The lack of effective treatment for these patients represents a major unmet clinical need...
January 5, 2018: Heart: Official Journal of the British Cardiac Society
https://www.readbyqxmd.com/read/29302838/gpkpdsim-a-simbiology%C3%A2-based-gui-application-for-pkpd-modeling-in-drug-development
#16
Iraj Hosseini, Anita Gajjala, Daniela Bumbaca Yadav, Siddharth Sukumaran, Saroja Ramanujan, Ricardo Paxson, Kapil Gadkar
Modeling and simulation (M&S) is increasingly used in drug development to characterize pharmacokinetic-pharmacodynamic (PKPD) relationships and support various efforts such as target feasibility assessment, molecule selection, human PK projection, and preclinical and clinical dose and schedule determination. While model development typically require mathematical modeling expertise, model exploration and simulations could in many cases be performed by scientists in various disciplines to support the design, analysis and interpretation of experimental studies...
January 4, 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29290094/a-candidate-tolerance-gene-identified-in-a-natural-population-of-field-voles-microtus-agrestis
#17
Klara M Wanelik, Michael Begon, Richard J Birtles, Janette E Bradley, Ida M Friberg, Joseph A Jackson, Christopher H Taylor, Anna G Thomason, Andrew K Turner, Steve Paterson
The animal immune response has hitherto been viewed primarily in the context of resistance only. However, individuals, can also employ a tolerance strategy to maintain good health in the face of on-going infection. To shed light on the genetic and physiological basis of tolerance, we use a natural population of field voles, Microtus agrestis, to search for an association between the expression of the transcription factor Gata3, previously identified as a marker of tolerance in this system, and polymorphism in 84 immune and non-immune genes...
December 31, 2017: Molecular Ecology
https://www.readbyqxmd.com/read/29290034/pharmacokinetics-of-dexmedetomidine-during-analgosedation-in-icu-patients
#18
Piotr Smuszkiewicz, Paweł Wiczling, Justyna Ber, Justyna Warzybok, Tomasz Małkiewicz, Jan Matysiak, Agnieszka Klupczyńska, Iwona Trojanowska, Zenon Kokot, Edmund Grześkowiak, Wojciech Krzyzanski, Agnieszka Bienert
Dexmedetomidine (DEX) is a fairly new alfa2-agonist which has been increasingly used in recent years for analgosedation, mostly because it offers a unique ability of providing both moderate level of sedation and analgesia without respiratory depression. Despite of many papers published, there are still only a few concerning the PK of the drug given as long-term infusion in ICU patients. The aim of this work was to characterize the population pharmacokinetics of dexmedetomidine and to investigate the potential benefits of individualization of drug dosing based on patient characteristics in the heterogeneous group of medical and surgical patients staying in intensive care unit...
December 30, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29285245/a-population-pharmacokinetic-model-for-individualised-dosage-regimens-of-vancomycin-in-chinese-neonates-and-young-infants
#19
Lin Song, Cui-Yao He, Nan-Ge Yin, Fang Liu, Yun-Tao Jia, Yao Liu
Population pharmacokinetic (PPK) modelling is an easy and impartment method for estimating drug concentration for use inindividualized therapy, especially for young patients and to help protect drug-induced diseases. The purpose of this study was to develop a PPK model for effective dosing of vancomycin in Chinese neonates and young infants. The PPK modelling tool Phoenix® NLME™ was use to assess demographic and routine clinical pharmacokinetic (PK) data retrospectively collected for patients admitted to Children's Hospital of Chongqing Medical University between 2011 and 2016...
December 1, 2017: Oncotarget
https://www.readbyqxmd.com/read/29278046/pregnancy-affects-the-pharmacokinetics-of-sildenafil-and-its-metabolite-in-the-rabbit
#20
Francesca M Russo, Paola Mian, Elke Hj Krekels, Kristel Van Calsteren, Dick Tibboel, Jan Deprest, Karel Allegaert
There is growing interest in the use of sildenafil during pregnancy for various maternal and fetal conditions. This study aims to investigate the effect of pregnancy on the maternal pharmacokinetics (PK) of sildenafil and its main metabolite desmethylsildenafil in rabbits. Using NONMEM, population PK-modelling was performed based on plasma samples from 31 rabbits of whom 15 were pregnant and 16 were not. All received a single subcutaneous sildenafil dose of 10mg/kg. One sample was obtained per rabbit at either 30, 60, 120, 360, 720 or 1320 minutes after sildenafil administration...
December 26, 2017: Xenobiotica; the Fate of Foreign Compounds in Biological Systems
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